Kurland 1961.
Study characteristics | ||
Methods | Type: clinical Design: parallel Objective: to determine differential effects of various phenothiazine derivatives on morbidity and severity of illness Treatment duration: 6 weeks Follow‐up duration (including treatment duration): 6 weeks Washout between cross‐over periods: NA |
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Data | Country: USA Condition: indication for tranquillisers, e.g. anxiety, agitation, restlessness Number of people randomised: 37 "referred" to active placebo and 37 to standard placebo (277 for all arms) Number of people analysed: 23 in active placebo group and 29 in standard placebo group with at least 1 assessment (at 2 weeks or later; 187 for all arms) |
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Comparisons | Active placebo: phenobarbital (IV: minimum daily dose 195 mg; oral: minimum daily dose 97.5 mg) Standard placebo: saline and lactose Experimental intervention: 6 arms with different phenothiazines (doses in brackets are minimum daily doses): promazine (IV: 150 mg; oral: 300 mg), chlorpromazine (IV: 75 mg; oral: 300 mg), mepazine (IV: 75 mg; oral: 75 mg), triflupromazine (IV: 75 mg; oral: 75 mg), prochlorperazine (IV: 15 mg; oral: 30 mg), and perphenazine (IV: 15 mg; oral: 24 mg) Administration: IV for the first 2 days, then oral |
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Outcomes | Participant‐reported outcome: none Observer‐reported outcome: Multidimensional Scale for Rating Psychiatric Patients (MSRPP) at the latest available assessment (2 weeks or later) Harm outcome: side effects causing termination of treatment Co‐intervention outcome: none |
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Terminology for active placebo | "Active placebo" a priori | |
Scores and unpleasantness of the active placebo | Adequacy: 2
Risk of therapeutic effect: 1 Unpleasant/neutral/pleasant: unpleasant |
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Funding and conflicts of interest | Funding unclear (funded by non‐commercial organisations, but several pharmaceutical companies are acknowledged). Conflicts of interest not reported. | |
Notes | SD for MSRPP scale imputed from other studies. | |
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Free from risk of bias arising from the randomisation process | Unclear | No information. |
Free from risk of bias in selection of the reported result All outcomes | Unclear | Outcome probably not selected on the basis of results. No other information. |